Gynecological Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Topical use of Sintilimab
Sponsors
Heilongjiang General Hospital of General Bureau of Agricultural Reclamation
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Eligible patients for this study must meet all the following criteria: 1. Understand the steps and content of the study, and voluntarily sign a written informed consent; 2. 18-90 years old female; 3. ECOG PS score 0-2; 4. According to solid tumors Efficacy evaluation standard (RECIST version 1.1), at least one imaging measurable lesion; 5. Advanced gynecological squamous cell carcinoma (including cervical squamous cell carcinoma, vaginal squamous cell carcinoma and vulvar squamous cell carcinoma) confirmed by histopathology Cancer), not suitable for surgery; 6. Have not previously received any systemic anti-tumor treatment for cervical squamous cell carcinoma, vaginal squamous cell carcinoma and vulvar squamous cell carcinoma; 7. Allow patients to receive palliative radiotherapy, but radiotherapy The end time is within 7 days before the first study drug administration; 8. With sufficient organ and bone marrow function, the laboratory tests performed by the screening must meet the following standards: 1) No blood transfusion or use of erythropoietin in the past 14 days Under the condition of hemoglobin>6g/dL; 2) Absolute neutrophil count (ANC) =1.5×10^9/L if granulocyte colony stimulating factor has not been used in the past 14 days; 3) If there is no blood transfusion in the past 14 days, Platelet (PLT) =9×10^9/L; 4) Total bilirubin (TBIL) =1.5×upper limit of normal (ULN) (Gilbert syndrome allows =3×ULN); 5) Alanine aminotransferase (ALT) and aspartate Transaminase (AST) = 2.5 × ULN (if there is liver metastasis, ALT and AST = 5 × ULN); 6) Serum creatinine (Cr) = 1.5 × ULN or endogenous creatinine clearance rate = 50mL/min (Cockcroft-Gault formula ); 7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) = 1.5 times ULN; 8) Normal thyroid function is defined as thyroid-stimulating hormone (TSH) within the normal range; if the baseline TSH is out of the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group; 9) Myocardial enzyme spectrum is within the normal range (if the investigator comprehensively judges that the simple laboratory abnormality is not clinically significant, it is also allowed to be included); 9. Expected to survive more than 3 months; 10. For female subjects of childbearing age, Received a urine or serum pregnancy test within 3 days before receiving the first study drug administration (day 1 of cycle 1) and the result was negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-bearing age are defined as at least 1 year after menopause, or have undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all subjects must be used during the entire treatment period until 120 days after the last study drug administration. Contraceptive measures with an annual failure rate of less than 1%; 12.Subjects must agree to collect blood samples during the treatment phase and agree to provide sufficient tumor tissue samples for PD-L1 expression detection. Including archived tumor samples (paraffin blocks or unstained sections with a quantity that meets the testing requirements of this research institute); if there is no archived tumor tissue sample, the subject agrees to receive a biopsy of the tumor lesion.
Exclusion criteria
Exclusion criteria: Patients meeting the following criteria were not eligible for this study: 1. Other malignant diseases (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and / or cancer in situ after radical resection) were diagnosed within 5 years before the first administration; 2. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 3. Having received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. Received systemic treatment with Chinese patent medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration; 5. Active autoimmune diseases requiring systemic treatment (such as the use of disease relief drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Replacement therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy; 6. The study was receiving systemic glucocorticoid therapy (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: physiological dose of Glucocorticoid (= 10 mg / day of prednisone or equivalent) is allowed; 7. Patients with clinically uncontrollable pleural effusion / peritoneal effusion (those who do not need drainage or whose effusion does not increase significantly after 3 days of drainage can be enrolled); 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Those who are known to be allergic to the active ingredients or excipients of sindilimab; 10. Not fully recovered from the toxicity and / or complications caused by any intervention (i.e. = grade 1 or reaching baseline, excluding fatigue or hair loss) before the start of treatment; 11. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1 / 2 antibody positive); 12. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number higher than the upper limit of the normal value in the laboratory of the research center); Note: hepatitis B patients who meet the following criteria can also be included in the study Before the first administration, if the HBV viral load is less than 1000 copies/ml (200 IU/ml), subjects should receive anti HBV treatment throughout the entire study treatment period to avoid virus reactivation; For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), preventive anti HBV treatment is not required, but virus reactivation needs to be closely monitored; Active HCV infected subjects (with positive HCV antibodies and HCV-RNA levels above the detection limit); 13.Inoculate the live vaccine within 30 days before the first administration (1st cycle, 1st day); Note: It is allowed to receive inactivated viral vaccines for seasonal influenza within 30 days before the first administration; However, it is not allowed to receive live attenuated influenza vaccines using intranasal medication. 14. Pregnant or lactating women; 15. There are any serious or uncont
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Disease control rate (DCR);Duration of remission (DOR) ;Overall survival (OS) ;To assess the safety and tolerability of sintilimab combined with platinum-containing dual-agent chemotherapy: including the incidence of adverse events (AE) and serious adverse events (SAE), and the incidence of AE/SAE leading to treatment discontinuation; | — |
Countries
China
Contacts
Public ContactLi XiaoLing
Heilongjiang General Hospital of General Bureau of Agricultural Reclamation
Outcome results
None listed